PIEZOWAVE2Recalls & reported problems across all models
Richard Wolf GmbH · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PIEZOWAVE2 model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 3 models of PIEZOWAVE2 by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2024 and Nov 24, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
PIEZOWAVE2 recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 9, 2025Open, Classified
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Z-1753-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported PIEZOWAVE2 problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Image Display Error/Artifact1
- Insufficient Device Problem Information1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- Stroke/CVA1
PIEZOWAVE2 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PIEZOWAVE2 100506USMassager, therapeutic, electric1 recall0 reports
- PIEZOWAVE2 100505Massager, therapeutic, electric3 reports
- PIEZOWAVE2 100506Massager, therapeutic, electric1 report
Recent PIEZOWAVE2 adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PIEZOWAVE 2 WAS USED ON A PATIENT FOR MYOFASCIAL ACOUSTIC COMPRESSION THERAPY (MYACT) ON THE LEFT LEG IN A MEDICAL FACILITY. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH AN ACUTE MENISCUS ROOT TEAR IN HER LEFT KNEE, CONFIRMED BY IMAGING, AS WELL AS PERSISTENT NEUROPATHIC SYMPTOMS; HOWEVER, BASED ON THE CURRENT CLINICAL ASSESSMENT AND AVAILABLE FINDINGS, A DIRECT CAUSAL LINK TO THE MYACT TREATMENT IS CONSIDERED UNLIKELY AND CANNOT BE CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633150 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RICHARD WOLF WAS INFORMED THAT A PATIENT EXPERIENCED A STROKE AFTER MANUAL CHIROPRACTIC MANIPULATION. PRIOR TO THE MANUAL CHIROPRACTIC TREATMENT, THE PIEZOWAVE WAS USED FOR MYOFASCIAL ACOUSTIC COMPRESSION MASSAGE. THERE IS NO INFORMATION AVAILABLE FROM THE CHIROPRACTOR ON THE SPECIFIC PIEZOWAVE CONTROL UNIT OR THERAPY SOURCE THAT WERE UTILIZED DURING THE TREATMENT. THE CHIROPRACTOR CONTINUES TO USE THE PIEZOWAVE UNITS AND THERAPY SOURCES FOR MYOFASCIAL ACOUSTIC COMPRESSION MASSAGE TREATMENT.
Patient problems: Stroke/CVA
MAUDE report 22442734 ↗InjuryJan 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
RICHARD WOLF GMBH BECAME AWARE OF A PATIENT ALLEGATION OF POTENTIAL INJURY VIA A LAWSUIT FILED IN THE USA. NO FURTHER DETAILS WERE PROVIDED IN THE LAWSUIT.
Patient problems: Insufficient Information
MAUDE report 21277398 ↗MalfunctionNov 12, 2024Image Display Error/Artifact; Smoking; Image Display Error/Artifact; Smoking
ACCORDING TO THE INFORMATION RECEIVED, A FAULT MESSAGE AND SUBSEQUENT SMOKE DEVELOPMENT OCCURRED DURING AN APPLICATION OF THE PIEZOWAVE 2. THE PIEZOWAVE WAS DISCONNECTED FROM THE POWER SUPPLY. THE USER REPORTS THAT THERE WAS NO DANGER TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20667015 ↗
Other Richard Wolf GmbH products
All Richard Wolf GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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